Efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.

Background: The efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention (PCI)(1) remains controversial in to date. Our meta-analysis was undertaken to evaluate the efficacy and safety of bivalirudin compared with heparin in patients undergoing PCI.

Methods: We searched PubMed, Cochrane Library, EMBASE, Clinical Trials.gov databases for randomized controlled trials (RCTs).(2) The primary efficacy endpoint was mortality. Secondary efficacy endpoints were incidence of major adverse cardiovascular events (MACE),(3) myocardial infarction (MI),(4) target vessel revascularization (TVR)(5) and stent thrombosis up to 30days and 1year. The safety endpoint was major bleeding up to 30days. Subgroup analyses were also conducted according to the clinical status of patients and the different use rate of GPI in two groups.

Results: 17 RCTs met the including criteria and 40,655 patients were included. No significant difference was observed in mortality (risk ratio [RR](6) 0.90; 95% confidence interval [CI](7) 0.77 to 1.05; p=0.19; I(2)=20%) and the risk of MACE (RR 1.02; 95% CI 0.96 to 1.09; p=0.45; I(2)=37%). Bivalirudin increased the risk of MI (RR 1.10; 95% CI 1.02 to 1.19; p=0.01; I(2)=13%), TVR (RR 1.20; 95% CI 1.04 to 1.38; p=0.01; I(2)=6%) and stent thrombosis (RR 1.32; 95% CI 1.08 to 1.60; p=0.006; I(2)=0%) but decreased the risk of major bleeding (RR 0.54; 95% CI 0.48 to 0.61; p<0.00001; I(2)=0).

Conclusion: Bivalirudin is associated with higher risk of MI, stent thrombosis and TVR but lower risk of major bleeding compared with heparin. The reduction of major bleeding is associated with the glycoprotein platelet IIb/IIIa inhibitor (GPI)(8) use rate.